01 1Aurobindo Pharma Limited
01 1BARICITINIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-11
Pay. Date : 2021-12-15
DMF Number : 36598
Submission : 2021-12-16
Status : Active
Type : II
20
Apitoria Pharma Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is BARICITINIB, with a corresponding US DMF Number 36598.
Remarkably, this DMF maintains an Active status since its submission on December 16, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 11, 2022, and payment made on December 15, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
